Cleared Traditional

DTX Studio diagnose

K172224 · Nobel Biocare AB · Radiology
Jan 2018
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K172224 is an FDA 510(k) clearance for the DTX Studio diagnose, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on January 11, 2018, 170 days after receiving the submission on July 25, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K172224 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2017
Decision Date January 11, 2018
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050